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Consumer OTC Drugs

OTC monograph update

This article was originally published in The Tan Sheet

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  • The Tan Sheet

Executive Summary

FDA sends Oct. 29 letter to Rep. Henry Waxman (D-Calif.) to provide an update on the number of monograph-related documents issued since the agency's last letter to the congressman ("The Tan Sheet" March 22, p. 1). FDA noted that since March, it has published one tentative final monograph, seven final monographs, two amendments to TFMS, 10 amendments to existing final monographs and four monograph-related documents. The agency plans to update Waxman "approximately every six months".

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